Articles
'Defensible' System Key to Successful Compliance
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Feb 5, 2007, 08:00

The FDA does not mandate how device companies should construct their internal systems regarding when to make reports about product malfunctions and when to make reports for product corrections and removals. Wise companies recognize that they are in the driver’s seat as long as they develop a “defensible” program, says Compliance-Alliance President Nancy Singer.
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